Some elements, such as arsenic (As) or lead (Pb), may be present in a drug product based on their natural occurrence. Others, such as palladium (Pd) or platinum (Pt) may be present as residues from catalysts which are used in active pharmaceutical ingredient (API) manufacture. Some elements are intentionally added to a drug product, whereas others leach into the drug product from the drug packaging, or, in the case of elements such as nickel (Ni) or copper (Cu), stem from manufacturing equipment. Due to their potentially adverse effects in the human body, and unknown effects on the stability and effectiveness of a drug product, the concentration of elemental impurities has to be determined in all drug products.

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Regulatory Authorities are responsible for ensuring the pharmaceutical products

Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. To achieve this, potentially toxic and harmful contaminants—including elemental impurities-must be identified, and limits defined for the maximum levels that a patient should be exposed to. Elemental impurities must be considered in a product risk assessment, appropriate for the intended route of administration of the final drug product. The likelihood of the element being naturally present (e.g. elements associated with a mineral-based raw material) or intentionally or unintentionally added (e.g. as a catalyst in chemical reactions, or via contamination from process equipment) must also be considered.

Invitron offers cGLP-accredited elemental impurities analysis services to pharmaceutical manufacturers, drug substance manufacturers, importers and wholesalers according to the USP, EP or your own method of analysis.

ICP-MS Testing Services

We undertake highly sensitive ICP-MS testing services in accordance with the updated ICH Q3D Guideline for Elemental Impurities. Sample types and matrices currently tested for trace elements include Organic and non-organic materials, Aqueous and non-aqueous materials. Drug Products may contain elemental residues as contaminants that may be harmful, even in small quantities. We ensure that the heavy metal or elemental impurities level in product meets the current regulatory guidelines for finished products. Invitron analyzes over 24 elements (metallic/non-metallic) that are mentioned in EP/USP with permitted daily exposures (PDE’s) from low parts per trillion (ppt) to high parts per million (ppm). The Mass Spectroscopy instrument utilizes a unique collision cell that eliminates polyatomic inferences, allowing the analysis of complex matrices. Our high matrix introduction (HMI) equipment allows direct analysis of samples containing high levels of dissolved solids.

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